Oxcarbazepine Versus Placebo in Childhood Autism

Oxcarbazepine Versus Placebo in Childhood Autism

The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.

The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism. Subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has any psychiatric or medical illnesses that would interfere with their ability to participate in this study. These evaluations may take up to an hour to complete. In addition, subjects will be asked to participate in a psychiatric interview designed to determine the child's diagnosis and current problem areas. The subject's parent will also be asked to fill out psychiatric questionnaires. The interview and questionnaires may take up to 4 hours to complete.

Inclusion Criteria:

• Subject has autism.
• Subject is between five and seventeen years of age
• Subject is not hospitalized.

Exclusion Criteria:

• Subject has been diagnosed with a psychopathic disorder or a mood disorder, including depression or bipolar disorder.
• Subject has displayed self-injurious behavior.
• Subject has an active seizure disorder or epilepsy.
• Subject has an unstable medical illness.
• Subject has undergone brain injury.
• Subject has a history of diabetes.
• Subject has a history of prior treatment with oxcarbazepine of 600 mg/day for 6 weeks.
• Subject has used other study drugs within the previous 30 days.
• Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.